LOTEPREDNOL ETABONATE AND TOBRAMYCIN (loteprednol etabonate)
This medication combines a corticosteroid with an antibiotic to help patients with inflammatory eye conditions where a bacterial infection is either present or likely to occur. It treats swelling, redness, and irritation in the front of the eye caused by allergies, chemical or thermal burns, and various inflammatory diseases. Healthcare providers use this combination when they need to manage inflammation while simultaneously protecting the eye from common bacterial pathogens.
How LOTEPREDNOL ETABONATE AND TOBRAMYCIN Works
The drug works by inducing proteins called lipocortins, which block the release of arachidonic acid to prevent the formation of inflammatory triggers like prostaglandins and leukotrienes. At the same time, the aminoglycoside component provides antibacterial activity against a broad range of susceptible organisms, including Staphylococci and Pseudomonas aeruginosa. This dual action reduces edema and scar formation while managing superficial ocular infections.
Details
- Status
- Prescription
- First Approved
- 2025-12-10
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS
LOTEPREDNOL ETABONATE AND TOBRAMYCIN Approval History
What LOTEPREDNOL ETABONATE AND TOBRAMYCIN Treats
9 indicationsLOTEPREDNOL ETABONATE AND TOBRAMYCIN is approved for 9 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inflammatory Ocular Conditions
- Bacterial Ocular Infection
- Allergic Conjunctivitis
- Superficial Punctate Keratitis
- Herpes Zoster Keratitis
- Iritis
- Cyclitis
- Chronic Anterior Uveitis
LOTEPREDNOL ETABONATE AND TOBRAMYCIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LOTEPREDNOL ETABONATE AND TOBRAMYCIN
3 of 19FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04555694 results posted | TC-2020-DexRes | Ph 4 | completed | Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax |
| NCT01437982 | 628 | Ph 4 | completed | A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5% |
| NCT01443442 results posted | MAC-06-11 | Ph 4 | completed | Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis |
| NCT01475643 results posted | 670 | Ph 3 | completed | Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children. |
| NCT03098953 | 881 | Ph 1 | completed | Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations |
| NCT01853696 results posted | 2013-0424 | Ph 4 | completed | Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty |
| NCT00699153 results posted | 526 | Ph 3 | completed | Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery |
| NCT00705159 results posted | 550 | Ph 4 | completed | Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis |
| NCT02028312 | CEI.HER-002 | Ph 4 | withdrawn | A Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis® |
| NCT01724892 | othana001 | Ph 4 | completed | Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing |
| NCT01060072 results posted | 577 | Ph 3 | completed | Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery |
| NCT01010633 results posted | 576 | Ph 3 | completed | Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LOTEPREDNOL ETABONATE AND TOBRAMYCIN FDA Label Details
Indications & Usage
LOTEPREDNOL ETABONATE AND TOBRAMYCIN is indicated for the treatment of Inflammatory Ocular Conditions; Bacterial Ocular Infection; Allergic Conjunctivitis; Superficial Punctate Keratitis; Herpes Zoster Keratitis; Iritis; Cyclitis; Chronic Anterior Uveitis; Corneal Injury.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.